GOST R 56395-2015 Medical laboratories Reduction of errors through risk management and continual improvement《医学实验室 通过风险管理和持续改进减少错误》.pdf

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5、 15189, / 73, :3.1 (laboratory error): , - , - , , .3.2 (active error): . . 2.1 563952015/ISO/TS 22367:20083.3 (cognitive error): - , - . 1 . 1. 2 (. 1).3.4 (failure modes and effects analysis); FMEA: - , / . 1 , - . 2 .3.5 (latent error): - , . , , - (. 2).3.6 (non-cognitive error): - - . 1 . 1. 2

6、(. 9).3.7 (failure mode and effects analysis): -, .4 4.1 , - .4.2 :- -;- , , ;- .4.3 :- -, ;- - , ;- , ;- - , .4.4 , , .2 563952015/ISO/TS 22367:20085 , , :- ;- ;- ;- . . , - (. ).6 , , . , .) :1) :- ;- ;- ;- ;- ;- -;- ;- ;- ;2) :- ;- ;- ;- ( ). ;3) :- ;- ;- ;- ;- ;- ;b) , :- ;c) :- ;- ;- -;d) :- , , ;) :- ;- ;- .3 563952015/ISO/TS 22367:20087 - .